Usability and Utility of Mindfulness-based Life Management Social Robots for Children and Adolescents in the Long-term Treatment
Evaluation of the Usability and Utility of Mindfulness-based Life Management Social Robots for Children and Adolescents in the Long-term Treatment Process
The purpose of this study is to apply social robot-based mindfulness-based life management content to pediatric and adolescent patients in the long-term disease treatment process and to assess usability and effectiveness of the social robot-based mindfulness-based life management content.
[Question 1] Effectiveness: Was the content on social robots effective in psychological adaptation of pediatric and adolescent patients?
[Question 2] Usability: Is there any difficulty in interacting through social robots applied in the hospital environment?
The participants conduct a preliminary survey and use robot content at least 10 times for the two weeks. Afterwards, follow-up surveys and in-depth interviews will be conducted.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to apply social robot-based mindfulness-based life management content to pediatric and adolescent patients in the long-term disease treatment process and to assess usability and effectiveness of the social robot-based mindfulness-based life management content.
[Intervention]
- Intervention period: 15-20 minutes or more per day for 14 days (at least 10 times in 2 weeks)
- Content: Life management content for mindfulness play and disease understanding
- Method of provision: Robot interaction using chatbot and remote conversation (mindfulness-based living management content and remote content will be provided for a total of 15 to 20 minutes)
[Question 1] Effectiveness: Was the content on social robots effective in psychological adaptation of pediatric and adolescent patients?
(Measure) Pre-post comparison of survey result values
- Child Emotional and Behavioral Disorder Assessment Scale (Korea-Child Behavior Checklist: K-CBCL) ② Child and Youth Mindfulness Scale (Korean Child and Adolescent Mindfulness Measure: K-CAMM) ③ Child and Youth Optimism Scale (The Children's Life Orientation Test: C-LOT)
[Question 2] Usability: Is there any difficulty in interacting through social robots applied in the hospital environment?
(Measure) User Experience Questionnaire(UEQ), In-depth Interview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Seoul, Korea, Republic of, 06351
- Samsung Medical Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pediatric patients aged 6 to 12 years old who is being treated after the diagnosis of a severe or chronic disease
- Pediatric patients who need hospital treatment, including inpatient or outpatient treatment, for more than 3 months
- Pediatric patients with a level of communication that can be understood and agreed to in this study
Exclusion Criteria:
- Those who disagree with this study
- Pediatric patients who are judged to be difficult to interact with robots due to communication difficulties
- Pediatric patients who has been diagnosed with or is being treated for mental illness with psychotic characteristics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Groups that use the Mindfulness-based Life Management Social Robots
Intervention period: 15-20 minutes or more per day for 14 days (at least 10 times in 2 weeks) Content: Life management content for mindfulness play and disease understanding Method of provision: Robot interaction using chatbot and remote conversation (mindfulness-based living management content and remote content will be provided for a total of 15 to 20 minutes) |
Mindfulness-based life management contents for pediatric patients operated by Social Robots
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation Scale of Child Emotional and Behavioral Disorders
Time Frame: 14 days
|
Measure and compare the score of Korea-Child Behavior Checklist (K-CBCL) before and after intervention.
Change in psychological adaptation scores among pediatric and adolescent patients as measured by a validated psychological adaptation questionnaire.
The questionnaire includes subscales for emotional regulation, coping mechanisms, and social engagement.
Results will be reported as mean changes in scores from baseline to 14 days.
|
14 days
|
|
Measurement of Mindfulness Scale for Children and Adolescents
Time Frame: 14 days
|
Measure and compare the score of Korean Child and Adolescent Mindfulness Measure (K-CAMM) before and after intervention.
Change in psychological adaptation scores among pediatric and adolescent patients as measured by a validated psychological adaptation questionnaire.
The questionnaire includes subscales for emotional regulation, coping mechanisms, and social engagement.
Results will be reported as mean changes in scores from baseline to 14 days.
|
14 days
|
|
Measurement of optimism in children and adolescents
Time Frame: 14 days
|
Measure and compare the score of The Children's Life Orientation Test (CLOT) before and after intervention.
Change in psychological adaptation scores among pediatric and adolescent patients as measured by a validated psychological adaptation questionnaire.
The questionnaire includes subscales for emotional regulation, coping mechanisms, and social engagement.
Results will be reported as mean changes in scores from baseline to 14 days.
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of Measurement User Experience Questionnaire Short Version (UEQs)
Time Frame: 14 days
|
Measurement of Measurement User Experience Questionnaire Short Version (UEQs) after intervention.
Number of reported difficulties in interacting with the social robot, as assessed by a semi-structured usability survey.
The survey includes items on ease of interaction, clarity of instructions, and overall user satisfaction.
Responses will be quantified on a Likert scale (1 = very difficult, 5 = very easy).
|
14 days
|
|
In-depth interview
Time Frame: 14 days
|
Interviews with study subjects based on the overall contents of the study
|
14 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Meong Hi Son, Samsung Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2023-03-057-006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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